ThromboGenics Business Update – H1 2017

7 Sep 2017

Leuven, Belgium – ThromboGenics NV (Euronext Brussels: THR), a biotechnology company developing novel medicines for diabetic eye disease, today issues a business update for the six month period ending 30 June, 2017.

ThromboGenics is developing an industry-leading pipeline of disease modifying drug candidates for diabetic eye disease, particularly diabetic retinopathy (DR) and diabetic macular edema (DME).

The clinical pipeline consists of THR-409 and THR-317, both from the Company’s in-house research. The Company’s pre-clinical candidates are THR-687, which was in-licensed from Galapagos NV in March 2016 and THR-149, which resulted from a research collaboration with Bicycle Therapeutics.

These products all have different modes of action and will allow the Company to address the four key segments of the rapidly growing diabetic eye disease market:

  • Non-proliferative DR
  • Proliferative DR
  • Non-proliferative DR with DME
  • Proliferative DR with DME

Dr. Patrik De Haes, ThromboGenics CEO,said: “ThromboGenics’ pipeline, both clinical and pre-clinical, which is targeting the key segments of the diabetic eye disease market, is progressing well.  With first results from our Phase II clinical study for THR-317 in the treatment of Diabetic Macular Edema expected in Q1 2018, and our pre-clinical products candidates poised to enter the clinic, we are well positioned to deliver multiple milestones over the next 12 months that could create significant value for our shareholders.”

 

Good Progress in Advancing Diabetic Eye Disease Portfolio

Oncurious NV grows pipeline with 5 immuno-oncology assets from VIB

Cash Position - €65.1 Million end H1 2017

Highlights

  • ThromboGenics is making good progress in advancing its portfolio of innovative medicines for the treatment of diabetic eye disease: its pipeline consists of 4 compounds targeting novel treatments for diabetic retinopathy (DR) - non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) - in the presence or absence of diabetic macular edema (DME)
  • ThromboGenics is conducting a Phase II clinical study evaluating THR-317 (anti-PLGF) for Diabetic Macular Edema (DME). The trial was initiated in January 2017 and assesses THR-317’s ability to improve best-corrected visual acuity (BCVA) and to reduce central retinal thickness in subjects with DME. Study results are expected during Q1 2018.
  • ThromboGenics is conducting a Phase IIa clinical study (CIRCLE) evaluating THR-409 (ocriplasmin) to induce complete posterior vitreous detachment (total PVD) and to prevent progression to PDR (a serious sight threatening condition) in patients with NPDR.
  • ThromboGenics is making good progress with its late-stage preclinical pipeline:
    • THR-687 (integrin antagonist) is being developed to treat a broad range of patients with diabetic retinopathy, with or without DME. THR-687 is expected to enter the clinic in H1 2018
    • THR-149 (pKal inhibitor) is being developed to treat edema associated with diabetic retinopathy. THR-149 is expected to enter the clinic in H1 2018.
  • ThromboGenics and BioInvent amended their long-standing agreement, which covers co-development of the novel anti-PLGF monoclonal antibody products (known as THR-317 and TB-403). Under the revised agreement, ThromboGenics will gain full and exclusive ownership of THR-317 for development and commercialization in all non-oncology indications. BioInvent will have a 5% share in the economic value of THR-317. The agreement will also see BioInvent increase its economic stake in the TB-403 project from 40% to 50%. The costs of this project will continue to be shared equally.
  • The European Commission granted orphan drug designation to TB-403 in January 2017. Oncurious NV is developing TB-403 for treatment of medulloblastoma, the most common pediatric malignant brain tumor.
  • In august 2017, Oncurious announces agreement with VIB for expanding its pipeline with 5 unique next generation immuno-oncology (IO) assets for treatment of a broad spectrum of cancers.
  • In H1 2017, ThromboGenics reported overall revenues of €2.7 million from JETREA®, including €0.8 million in royalty income from its partner Alcon (Novartis).
  • Cash and investments were €65.1 million as of the end of June 2017. This compares to €80.1 million as of December 31, 2016.